Colorectal Cancer Detection by Means of Optical Fluoroscopy

NCT01286064 | Unknown DMC

• 1 other identifier: INT-D178768
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present prospective study was to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. For years, serum tumor markers have been studied for the diagnosis and follow-up of colorectal cancer, among which carcinoembryonic antigen (CEA) has achieved promising results. However, the sensitivity of CEA for colorectal cancer is less than 25% and elevated CEA levels also occur in patients with benign disease, as well as in patients with other carcinomas. Nevertheless, surveillance programs are often based on the CEA test and combination with other markers is at present a matter of research. Alternative methods based on optical fluoroscopy have been introduced in experimental stages for clinical diagnosis of cancer. Few studies have been reported on the application of native fluorescence spectroscopy of biofluids in the diagnosis of tumoral diseases. The above reported findings prompted us to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. For this purpose, the blood of patients was collected and the fluorescence Preliminary measurements on plasma of patients bearing colon cancer showed that the fluorescence spectra were mainly characterized by the presence of an emission peaking at 620-630 nm, whose excitation spectrum peaked at 405 nm. Hence, an excitation wavelength of 405 nm was selected for the study. The fluorescence emission spectra were recorded in the range of 430-700 nm.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma,; colorectal tumors,; endogenous porphyrins,; fluorescence,; tumor markers.

Outcome Measures

Primary Outcomes (1)

• Colorectal cancer detection by means of optical fluoroscopy

  investigated the possible role of the native fluorescence of blood plasma in the management of colorectal cancer (CRC) and its feasibility as a new tumor marker.

  18 months

Study Arms (2)

patient with colo-rectal cancer

EXPERIMENTAL

fluorescence spectra will be mainly characterized by the presence of an emission peaking at 620-630 nm

Device: Optical Fluoroscopy

patient without colo-rectal cancer

ACTIVE COMPARATOR

fluorescence spectra will be characterized by the absence of an emission peaking at 620-630 nm

Device: Optical Fluoroscopy

Interventions

Optical Fluoroscopy DEVICE

Lithium-heparin was added to the blood samples to prevent coagulation. The samples were then centrifuged and the plasma was removed without disturbing the buffy coat and the erythrocyte sediments. The separated changes in the enzyme associated with heme biosynthesis have been reported for peripheral mononuclear cells in patients with epithelial tumors and metastatic spread. plasma was stored at -20 °C until assayed. For fluorescence measurements, analytical grade acetone was added to plasma in a 1:1 ratio by volume and the mixture was centrifuged. The clear supernatant was placed in a quartz cuvette of 1 cm path length for further analysis. Fluorescence analysis of blood plasma was performed by means of a spectrofluorometer (Model F-3000, Hitachi, Ltd., Tokyo, Japan).

patient with colo-rectal cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastrointestinal disease clinical symptoms related to colorectal cancer risk endoscopy

You may not qualify if:

• Age younger than 18 years or more than 75 years, history of psychiatric illness, preoperative chemo/radiotherapy.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy, 20133, Italy

RECRUITING

Related Links

• Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy

MeSH Terms

Conditions

Colorectal Neoplasms; Adenocarcinoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• alberto vannelli, md

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  STUDY DIRECTOR

Central Study Contacts

vannelli alberto, MD

CONTACT

00390223902044; alberto.vannelli@istitutotumori.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 31, 2011
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: April 1, 2011
• Last Updated: January 31, 2011

Record last verified: 2010-09

Locations

IT (1)